FDA-regulated does not mean FDA-approved. FDA does not have the legal authority to approve cosmetics before they go on the market, although we do approve color additives used in them (except coal tar hair dyes).

However, under the law, cosmetics must not be "adulterated" or "misbranded." For example, they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

FDA can take action against a cosmetic on the market if we have reliable information showing that it is adulterated or misbranded. FDA takes action within our legal authority, based on public health priorities and available resources.

FDA Authority Over Cosmetics

The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.

The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA regulates cosmetics under the authority of these laws.

In the United States, federal laws are enacted by Congress. In order to make the laws work on a day-to-day level, Congress authorizes certain government agencies. such as FDA, to create regulations. A change in FDA's legal authority over cosmetics would require Congress to change the law.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things,

• "The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded" [FD&C Act, sec. 301(a); 21 U.S.C. 331(a)].
• "The adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce" [FD&C Act, sec. 301(b); 21 U.S.C. 331(b)].
• "The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise"[FD&C Act, sec. 301(c); 21 U.S.C. 331(c)].
• "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded" [FD&C Act, sec. 301(k); 21 U.S.C. 331(k)].

This means that nearly everyone involved in cosmetics in interstate commerce, such as manufacturers, packers, distributors, and retailers, is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded, even if someone else caused the adulteration or misbranding in the first place. If you introduce it into interstate commerce or receive it in interstate commerce, you are responsible. The law applies to components and packaging as well as to finished products.

The FD&C Act describes what constitutes interstate commerce, adulteration, and misbranding. It also authorizes FDA to take legal action if cosmetics are adulterated or misbranded. In addition, the Fair Packaging and Labeling Act (FPLA) requires specific label information. Violations of the FPLA result in misbranding.

What Makes a Cosmetic Adulterated or Misbranded?

Section 601 of the FD&C Act [21 U.S.C. 361] describes what causes a cosmetic to be considered adulterated:

"A cosmetic shall be deemed to be adulterated--

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use that are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution-This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)." (Section 721(a) of the FD&C Act [21 U.S.C. 379(a)], states the circumstances under which color additives are deemed unsafe.)

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered misbranded:

"A cosmetic shall be deemed to be misbranded--

(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(d) If its container is so made, formed, or filled as to be misleading.
(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).
(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.